Fluoridated Milk and Enamel Caries in Adolescents

NCT06684405 | Completed

• 1 other identifier: Malmö University
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. The main questions it aims to answer are:

• Does fluoridated milk lower the number of caries lesions in teeth over time?
• Does fluoridated milk lower the number of enamel caries lesions over time? Researchers will compare an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk. The 12-13 year participants will:
• be examined at a baseline and once yearly up to 2 years
• be provided directly with the doses every second month at their dental clinic
• take the fluid daily

Conditions

Caries,Dental

Keywords

adolescents; flouridated milk; caries prevention; enamel caries; bitewing radiography

Outcome Measures

Primary Outcomes (1)

• Caries development in enamel and dentine

  caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces)

  From enrollment to the end of intervention at 2 years

Secondary Outcomes (2)

• Caries lesion arrest

  From enrollment to the end of intervention at 2 years

• Caries lesion progression

  From enrollment to the end of intervention at 2 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The subjects in the intervention group received individually packaged daily doses of sodium fluoride solution in 0.5 ml sterile water to be added to 200 ml of milk

Dietary Supplement: sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)

Control group

PLACEBO COMPARATOR

Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.

Dietary Supplement: Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.

Interventions

sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) DIETARY_SUPPLEMENT

Intervention

Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. DIETARY_SUPPLEMENT

Control group

Eligibility Criteria

• Age: 12 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• adolescents of both sexes, aged 12-¬13
• healthy (no oral disease or systemic disease possibly affecting the oral cavity). Health declaration used in the dental clinic was utilized to confirm health status
• adolescents with permanent posterior teeth/no primary molar teeth present and second premolars in contact with the mesial surface of the first molars
• adolescents who, together with their parents or guardians, gave informed written consent to participate. Data confidentiality and the right to withdraw from the study at any time were warranted to the adolescents in writing.

You may not qualify if:

• None

Sponsors & Collaborators

• Malmö University: lead

Study Sites (1)

Faculty of Odontology, Malmo University

Malmo, Sweden

Location

Related Publications (3)

• Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

  PMID: 17518963 BACKGROUND

• Senneby A, Elfvin M, Stebring-Franzon C, Rohlin M. A novel classification system for assessment of approximal caries lesion progression in bitewing radiographs. Dentomaxillofac Radiol. 2016;45(5):20160039. doi: 10.1259/dmfr.20160039. Epub 2016 Apr 4.

  PMID: 27043978 BACKGROUND

• Rohlin M, Neilands J, Davies JR, Isberg PE, Wickstrom C, Svensater G. Fluoridated milk is effective in prevention of enamel caries in adolescents: a randomised trial. Acta Odontol Scand. 2025 Dec 29;84:673-684. doi: 10.2340/aos.v84.45271.

  PMID: 41460820 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Milk

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Gunnel Svensäter

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects and their parents/guardians, the clinicians performing the examinations, the staff-members delivering the packages with solutions to the subjects, the trial investigators and the outcome assessors were blind to the allocation and group assignment. The solutions were distributed to the subjects in tubes pre-labelled with code numbers. The tubes had the same design independent of the solution with fluoride or placebo. After the randomization, lists with code numbers were saved as sealed files in a safety-deposit box. The code was broken when the study was completed, and the assessment of the outcome measures were processed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two parallel arms; an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2012
• Primary Completion: May 30, 2020
• Study Completion: June 1, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)